Company News

ITM Isotope Technologies Munich SE (ITM) has secured €255 million from an investor syndicate led by Temasek of Singapore to advance its pipeline of radiopharmaceuticals for the treatment of cancer. The round, which was also supported by BlackRock Alternatives and the Qatar Investment Authority, will help advance the company’s lead product for neuroendocrine tumours and expand capacity for the production of targeted radionuclide therapies. These are a type of radiation therapy in which a radioactive chemical is linked to a cell-targeting molecule such as a peptide or small molecule.

Quell Therapeutics Ltd has secured its first major partnership for the development of its regulatory T cell technology for the treatment of autoimmune diseases. An agreement with AstraZeneca Plc, announced on 9 June, will bring the two parties together to research and develop potential therapies for Type 1 diabetes and inflammatory bowel disease. AstraZeneca is to make an $85 million upfront payment to Quell comprising cash and equity. If the collaboration is successful, with the commercialistion of new products, milestone payments could exceed $2 billion.

An advisory committee that reviews drug applications for the US Food and Drug Administration has concluded that the Alzheimer’s disease treatment Leqembi (lecanemab) has shown clinical benefit for patients and should be approved. The Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously to recommend full approval on 9 June. A decision by the FDA is expected on 6 July.

A lawsuit has been filed by the US Chamber of Commerce against the American government seeking to revoke part of the Inflation Reduction Act that gives the government powers to negotiate the prices of some drugs directly with industry. The suit was filed on 9 June in the US District Court in Dayton, Ohio saying the legislation violates constitutional protections for free enterprise. Merck & Co Inc registered a similar complaint in the US District Court in Washington DC on 6 June.

Switzerland-based BC Platforms AG is to strengthen its position as a provider of real world data for clinical research with the acquisition of 4Pharma Ltd, a contract research organisation located in Turku Finland. The acquisition, announced on 1 June, will bring the Finnish company’s research capabilities, which include medical writing and data collection, into BC Platform’s global service offering. The financial terms of the transaction were not disclosed.

The US Food and Drug Administration approved a second vaccine on 31 May to protect older adults against infection from the respiratory syncytial virus (RSV). The vaccine, Abrysvo, was developed by Pfizer Inc and is expected to be launched before the next RSV season which typically starts in the autumn and peaks in the winter. The decision follows the agency’s authorisation on 3 May of a vaccine for the same disease from GSK Plc.

Ariceum Therapeutics GmbH announced the acquisition of UK-based Theragnostics Ltd on 1 June giving it a US Food and Drug Administration approved diagnostic and a pipeline of radiolabelled small molecule inhibitors for the treatment of aggressive cancers.

This is the second major business transaction for the German radiopharmaceutical company, which was co-founded in 2021 by venture capital and private equity investors. The first was a peptide-based research collaboration with UCB SA of Belgium, announced on 11 May.

The European Medicines Agency is recommending that Adakveo (crizanlizumab), a medicine for preventing vaso-occlusive crises in patients with sickle cell disease, be withdrawn from the EU market. This follows data from a post-authorisation study showing little benefit and a higher rate of adverse events. Developed by Novartis, Adakveo was given a conditional approval on 28 October 2020. Full approval was contingent on positive data from the STAND follow-up study.

Data from a Phase 3 trial of a combination vaccine candidate to prevent meningococcal disease, a bacterial infection that can cause death or permanent disability, were positive, according to the developer GSK Plc. The vaccine candidate showed non-inferiority in primary endpoints for five Neisseria meningitidis serogroups compared with Bexsero and Menveo, two marketed GSK vaccines, which together cover the same serogroups. The five Neisseria meningitidis serogroups account for nearly all invasive meningococcal disease cases in the world.

Gene editing technology has been used by an international team of researchers to create a new therapeutic that targets Escherichia coli in the guts of patients with blood cancers who are at risk of infection. A preclinical study of the new therapy was published in Nature Biotechnology on 4 May. The therapy, SNIPR001, was developed by Denmark-based SNIPR Biome ApS which is currently conducting a Phase 1 trial of the drug in the US. The drug has received a fast track designation from the Food and Drug Administration.